Chart Review of the Efficacy of the GenesisPlus 1064 nm N... | NCT02445495

Studies
Chart Review of the Efficacy of the GenesisPlus 1064 nm Nd:YAG Laser in the Treatment of Onychomycosis

NCT02445495

Sponsor

Jason K Rivers, MD, FRCPC, FAAD

Status

Completed

Last Update Posted

May 15, 2015Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Onychomycosis

Interventions

GenesisPlus 1064 nm Nd:YAG laser

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2013

Primary Completion Date

Nov 2014Actual

Completion Date

Nov 2014Actual

First Submitted Date

Apr 30, 2015

First Submission Date that Met QC Criteria

May 12, 2015

First Posted Date

May 15, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2015

Last Update Posted Date

May 15, 2015Estimated

Name	Class
Cutera Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine if toenail onychomycosis can be reduced by means of exposure to laser energy from the Cutera® GenesisPlus 1064 Nd:YAG laser system.

Detailed Description

This is a retrospective, open-label, single-centre study for the collection of clinical data on the efficacy and safety of the Cutera® GenesisPlus 1064 nm Nd:YAG laser for the treatment of nail fungus (onychomycosis). Safety and efficacy of treatment with the GenesisPlus laser will be evaluated by (1) assessment of subject's great toenail photographs at baseline and after two treatments with GenesisPlus Laser utilizing planimetry measurement of infected vs. clear nail area in target toenail photographs, (2) by clinical and subjective review of acute and follow up adverse events that may have resulted from laser treatment of the target toenails.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Name	Type	Description	Arm Group Labels	Other Names
GenesisPlus 1064 nm Nd:YAG laser	Device	Genesis Plus 1064 nm Nd: YAG laser to treat onychomycosis		Cutera®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in % of infected toenail involvement	onychomycosis involvement	change from baseline up to 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or Female subjects, age 18 to 80 years (inclusive).
Subject with a clinical diagnosis of onychomycosis of one or both great toenails at baseline.
Subject with a positive potassium hydroxide (KOH) stain and/or fungal culture.
Subject has baseline and post treatment digital photographs of target great toenails.
Subjects provided informed consent for treatment of nails with the Cutera GenesisPlus laser system.

Exclusion Criteria:

Subjects have received laser treatment of the infected great toenail(s) with a non-Cutera® laser system within twelve (12) months prior to Cutera® GenesisPlus laser treatment.
Subjects have had a history or clinical diagnosis of moccasin type tinea pedis, lichen planus, psoriasis or bacterial nail infection.
Subjects had a history or clinical diagnosis of coexisting disorders that may potentially demonstrate nail manifestations.
Systemic antifungal medication within six (6) months prior to or following Cutera® GenesisPlus laser treatment.
Subjects who have had a history or clinical diagnosis of repetitive nail trauma prior to treatment.
Subjects who have participated in any clinical research study within thirty (30) days prior to or within 210 days following final Cutera® GenesisPlus laser treatment.
Subjects who were pregnant or breastfeeding.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

100 participants at primary clinic

Sampling Method

Non-Probability Sample

ID	Term
D014005	Tinea
D003881	Dermatomycoses
D009181	Mycoses
D001423	Bacterial Infections and Mycoses